Mapracorat Ophthalmic Suspension for the Treatment of Ocular Inflammation Following Cataract Surgery

Bausch + Lomb

Status and phase

Completed

Phase 3

Conditions

Cataract

Treatments

Drug: Mapracorat

Drug: Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT01230125

663

Details and patient eligibility

About

The objective of this clinical study is to compare the safety and efficacy of Mapracorat Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

Enrollment

311 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants who are candidates for routine, uncomplicated cataract surgery
Participants who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye.
Participants must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.

Exclusion criteria

Participants who are expected to require concurrent ocular therapy (either eye) with nonsteroidal anti-inflammatory drugs (NSAIDs), mast cell stabilizers, antihistamines, or decongestants.
Participants who are expected to require treatment with any systemic or ocular (either eye) corticosteroids or glucocorticoids.
Participants who are expected to require concurrent ocular therapy with immunosuppressants (eg, Restasis).
Participants who have known hypersensitivity or contraindication to the study drug(s) or their components.
Participants participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.